# K173500: NMF004A

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 8, 2018 after 115 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042819 (2004). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091388: GCUC-505, GC America, Inc. (2009) Summary page 4.
- K123631: MFP-051, GC America, Inc. (2013) Summary page 4.
- K082434: GDLS-200, GC America, Inc. (2008) Summary page 4.

## Most influential descendants
- K251946: G aenial Universal Injectable II (2025), 0 descendants of its own
- K250317: EsFlow PLUS (2025), 0 descendants of its own

## Indications for use
1. Liner or base 2. Blocking out undercuts 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. Direct restorative for Class I, II, III, IV, V cavities 7. Core build-up

Source page: https://510kreport.com/device/K173500
Methodology: https://510kreport.com/methodology